OVERVIEW
AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (AFFIRM)
PROTOCOL SUMMARY
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Primary Biliary Cholangitis
Gender
N/A
Date
September 2023 - August 2030
Study Type
Interventional
Study Phase
Phase 3
Product
Seladelpar, Placebo
Eligibility information
Inclusion criteria
- Individuals must meet the following criteria to be eligible for study participation:
- 1. Must be at least 18 years old.
- 2. Must have a confirmed prior diagnosis of PBC
- 3. Evidence of cirrhosis
- 4. CP Score A or B
- 5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
- 6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)
Exclusion criteria
- Individuals must not meet any of the following criteria to be eligible for study participation:
- 1. Prior exposure to seladelpar
- 2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
- 3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
- 4. Decompensated cirrhosis
- 5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
- 6. Hospitalization for liver-related complication within 12 weeks of Screening
- 7. Laboratory parameters at Screening:
- 1. Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
- 2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
- 3. Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN
- 4. Platelet count ≤50×10^3/µL
- 5. Albumin ≤2.8 g/dL
- 6. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m^2
- 7. MELD score >12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.
- 8. Serum alpha-fetoprotein (AFP) >20 ng/mL
- 9. INR >1.7
- 8. CP-C cirrhosis
- 9. History or presence of other concomitant liver diseases
Locations
Locations (205)
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
St. Joseph's Hospital and Medical Center - 350 W. Thomas
Phoenix, Arizona, United States, 85013
SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Cedar Sinai Medical Center
Los Angeles, California, United States, 90048
California Liver Research Institute
Pasadena, California, United States, 91105
Stanford University
Redwood City, California, United States, 94063
University of California, Davis Medical Center
Sacramento, California, United States, 95817
California Pacific Medical Center - Sutter Pacific Medical Foundation
San Francisco, California, United States, 94109
Connie Frank Transplant Center at UCSF
San Francisco, California, United States, 94143
Kaiser Permanente - South San Francisco Medical Center
South San Francisco, California, United States, 94080
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, United States, 33912
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States, 33136
Covenant Metabolic Specialists, LLC
Sarasota, Florida, United States, 33912
Piedmont Atlanta Hospital / Piedmont Transplant Institute
Atlanta, Georgia, United States, 30309
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, United States, 40202
Ochsner Clinic Foundation
Jefferson, Louisiana, United States, 70121
University Health System - East Jefferson General Hospital Campus
New Orleans, Louisiana, United States, 70112
Walter Reed National Military
Bethesda, Maryland, United States, 20889
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Henry Ford Medical Center - Columbus
Detroit, Michigan, United States, 48202
University of Rochester Medical Center - Strong Memorial Hospital
Rochester, Minnesota, United States, 14642
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, United States, 11030
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
University Hosptials Cleveland Medical Center
Cleveland, Ohio, United States, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania, United States, 15213
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
University of Texas Southwestern Medical Center, Professional Office Building One
Dallas, Texas, United States, 75390
American Research Corporation
San Antonio, Texas, United States, 78215
Pinnacle Clinical Research, PLLC
San Antonio, Texas, United States, 78229
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
Fairfax, Virginia, United States, 22031
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States, 23602
VCU Health Clinical Research Services Unit (CRSU)
Richmond, Virginia, United States, 23298
Liver Institute Northwest
Seattle, Washington, United States, 98105
Consultorios Médicos Dr. Doreski - PPDS
Buenos Aires, Argentina, 1426
Centro de Investigación y Prevención Cardiovascular
Buenos Aires, Argentina, C1061
AES - AS - Glenny Corp. S.A. Buenos Aires
Buenos Aires, Argentina, C1430
CINME S.A. - Centro de Investigaciones Metabólicas
Recoleta, Argentina, C1118AAT
Princess Alexandra Hospital
Queensland, Queensland, Australia, 4102
Flinders Medical Center
Adelaide, South Australia, Australia, 5042
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia, 3168
Klinikum Wels-Grieskirchen GmbH - Standort Wels
Wels, Austria, 4600
Centre Hospitalier de l'Universite de Montreal
Montreal, Canada, H2L 4M1
Centro de Investigación y Prevención Cardiovascular
La Serena, Chile, 1720506
Pontificia Universidad Católica de Chile
Santiago, Chile, 8320000
Beijing Youan Hospital, Capital Medical University
Beijing, China, 100000
Beijing Ditan Hospital, Capital Medical University
Beijing, China, 100015
Beijing Friendship Hospital, Capital Medical University
Beijing, China, 100050
West China Hospital of Sichuan University
Chengdu, China, 610047
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China, 401336
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, China,
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China, 510630
The First Affiliated Hospital of Anhui Medical University
Hefei, China, 230032
The First People's Hospital of Yunnan Province
Kunming, China, 650032
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, China, 200001
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China, 830054
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430030
The First Affiliated Hospital of PLA Air Force Medical University
Xi'an, China, 710032
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710061
The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, China, 310009
The Third People's Hospital of Zhenjiang
Zhenjiang, China, 212021
Hôpital Claude Huriez-Lille-1 Place de Verdun
Lille, France, 59000
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
Lyon, France, 69317
Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris
Paris, France, 75012
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67000
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France, 54500
Charité Campus Virchow-Klinikum-Augustenburger Platz 1
Berlin, Germany, 13353
Gastroenterologisch - Hepatologisches MVZ Kiel GmbH
Kiel, Germany, 24146
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, Greece, 546 41
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, Hungary, 7400
Liver Unit, institute of Gasteroenterology and Liver Diseases
Jerusalem, Israel, 91120
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Israel, 5266202
Tel Aviv Sourasky Medical Center Ichilov
Tel Aviv, Israel, 64239
Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi
Ancona, Italy, 60020
IRCCS Saverio de Bellis-UOSD "Epatopatie"
Castellana Grotte, Italy, 70013
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico
Milan, Italy, 20142
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena, Italy, 41126
A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia
Palermo, Italy, 90127
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Italy, 71013
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca, Mexico, 62170
Centro De Investigacion Y Gastroenterogia, S.C.
México, Mexico, 76806
Oaxaca Site Management Organization - Hospital - OSMO - PPDS
Oaxaca City, Mexico, 71256
Kyungpook National University Hospital
Daegu, South Korea, 41944
Chonnam National University Hospital
Gwangju, South Korea, 61455
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 3722
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 6591
Complexo Hospitalario Universitario De Santiago
A Coruña, Spain, 15706
Hospital Universitario Fundacion Alcorcon
Alcorcón, Spain, 28925
Hospital Universitario Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Universitario Vall d'Hebron-VIHR
Barcelona, Spain, 08035
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41010
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 80756
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Adana City Training and Research Hospital
Adana, Turkey (Türkiye), 1370
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
Gaziantep, Turkey (Türkiye), 27630
Uludag University Medical Faculty
Görükle, Turkey (Türkiye), 16059
Kocaeli University Medical Faculty Hospital
Kocaeli, Turkey (Türkiye), 41380
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, Turkey (Türkiye), 33110
Marmara University Pendik Training and Research Hospital
Pendik, Turkey (Türkiye), 34899
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize Merkez, Turkey (Türkiye), 53020
East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
Ipswich, United Kingdom, IP4 5PD
St James's University Hospital - PPDS
Leeds, United Kingdom, LS9 7TF
Sheffield teaching hospital NHS foundation trust
Sheffield, United Kingdom, S10 2JF
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